A Study of ADRX-0405 in Subjects With Select Advanced Solid Tumors

Recruiting now · Phase 1

Conditions studied: Solid Tumors

In brief

The primary purpose of this study is to assess the safety, tolerability, and pharmacokinetics, and to identify the optimal dose of ADRX-0405 in patients with select advanced solid tumors.

Key facts

Study ID

NCT06710379

Run by

Adcentrx Therapeutics

People needed

68

Starts

2024-12-30

Expected to finish

2026-12-01

Last updated by the study team

2025-04-09

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Phase 1a Dose Escalation: Subjects with histologically confirmed select advanced solid tumors, including metastatic castration resistant prostate cancer (mCRPC), gastric cancer (GC), and non-small cell lung cancer (NSCLC).
• Phase 1b Dose Expansion: Subjects with histologically confirmed prostate adenocarcinoma that is confirmed to be castration resistant (i.e., serum testosterone < 50 ng/dL [< 2.0 nM]) and that is intolerant/resistant to standard of care (SOC) therapies.
• Measurable disease according to RECIST version 1.1 or evaluable disease per PCWG3 for subjects with prostate cancer
• Eastern Cooperative Oncology Group (ECOG) performance status of 0-1 in 1a; 0-2 in 1b
• Adequate hematologic, liver, and renal function

You may not qualify if…

• Active and uncontrolled central nervous system metastases
• Significant cardiovascular disease
• History of another malignancy other than the one for which the subject is being treated on this study within 3 years
• Receipt of any anticancer or investigational therapy within: 5 elimination half-lives or 14 days (whichever is less); 4 weeks for any therapeutic radiopharmaceutical for prostate cancer
• History of (non-infectious) ILD/pneumonitis that required steroids within 2 years of study enrollment, has current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at screening.
• Receiving systemic antimicrobial treatment for active infection; routine antimicrobial prophylaxis is permitted

Where it is running

• City of Hope — Duarte, California, United States (enrolling)
• UCLA — Santa Monica, California, United States (enrolling)
• START Midwest — Grand Rapids, Michigan, United States (enrolling)
• University of Minnesota Masonic Cancer Center — Minneapolis, Minnesota, United States (enrolling)
• NEXT Austin — Austin, Texas, United States (enrolling)
• The University of Texas MD Anderson Cancer Center — Houston, Texas, United States (enrolling)
• START Mountain Region — West Valley City, Utah, United States (enrolling)
• NEXT Virginia — Fairfax, Virginia, United States (enrolling)

Full record on ClinicalTrials.gov

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